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Effectiveness of Bracing in Preventing Scoliosis in Children With Spinal Cord Injury

NCT00256672 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2008-06-13

No results posted yet for this study

Summary

The purpose of this study is to determine whether full-time high dose prophylactic bracing (23 hours or more per day) is more effective than low dose bracing (12 hours or less per day) in preventing or delaying spinal curve progression in children with scoliosis after spinal cord injury.

Conditions

  • Scoliosis

Interventions

DEVICE

Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam

TLSO back brace, Flex-Foam (Posterior Opening)

Sponsors & Collaborators

  • Shriners Hospitals for Children

    lead OTHER

Principal Investigators

  • Craig M McDonald, MD · Shriners Hospital for Children, Northern California

  • Randal R Betz, MD · Shriners Hospital for Children, Philadelphia

  • Lawrence Vogel, MD · Shriners Hospital for Children, Chicago

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2009-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00256672 on ClinicalTrials.gov